Manager Product Quality Mat Release

Summary of the Position: The PQMR Senior Manager will operate under flexibility to perform the necessary activities to meet the business needs and ensure compliance requirements and manufacturing/ releaseschedules are met.  The PQ Senior Manager supports four core activities: 1) Quality Review of Control Logs and Raw Material Assay Reports; 2) Raw Material and Finished Goods Batch Disposition; 3) Quality Systems Coordination, and 4) Compliance, Performance, and Leadership. Key Accountabilities: cGMP Review of Control Logs and Raw Material Assay Reports (25%) Performs cGMP review of PQMR Control Logs, Raw Material Assay Reports, QC Test Results, and Vendor Documentation according to site procedures, cGMP, FDA's 21 CFR, and other applicable health authority regulations for raw material release. Complete all required system transactions associated with the control log review process. Follow up and work effectively with colleagues throughout the organization to ensure timely disposition of product. Raw Material and Finished Goods Batch Disposition (40%) Verify that the respective batch control log and Raw Material Assay Report has been satisfactorily reviewed and a recommendation for disposition has been made by inspector.  Verify the lot is not on hold (i.e., deviations, change controls, etc.) prior to batch disposition. Complete all required system transactions associated with the batch disposition process.  Provide notification of raw material and or finished batch disposition to the Warehouse, Procurement, Materials Management, and Distribution departments so that the product can be properly status tagged. Place batches on hold post disposition. Quality Systems Manager (15%)  As assigned by PQ management, the incumbent must be able to perform the following tasks for the department: Lead, track and manage departmental Change Controls Develop, track and manage departmental CAPAs Track and manage audit observation remediation Revise departmental procedures as needed Compliance, Performance, and Leadership (20%) Evaluates and enhances procedures and processes in accordance with internal and external standards and requirements to maximize performance. Schedule and assign the timely completion of control log and RMAR reviews in addition to disposition of Raw Materials and Finished Goods. Lead deviation investigations as assigned. Perform change control assessments, as assigned. Perform special projects as assigned by PQ Deputy Director. Train and perform PQ Material Release approval process. Attend and provide expert assessments to the Supplier Quality Board Act as Team Leader or Team Member on assigned project team(s).  This includes, but is not limited to, review and approval of project related requirement documents, IS Change Requests, investigative protocols, reports, user and functional specifications, etc. Act as delegate to PQ MR Deputy Director for the review and approval of departmental SOP/SWI and the review and Final Approver of Raw Material Component, and Label Specifications. Meet department safety, quality, productivity, cost targets and goals in a compliant and timely manner. Support Regulatory and internal inspections as Subject Matter Expert for Material Release function Serve as Qualified Trainer for Material Release function Serve as back up to PQ MR Deputy Director, as assigned. Major Challenges: Each individual working in a GMP area is responsible for following the documented processes and recording GMP data correctly.  It must be emphasized that non-compliance in following a GMP process or procedure may result in regulatory observations, up to and including recall and a significant risk to the site's continued operation. Attention to detail in recording GMP data right first time into GXP documents.  Documentation practices must be of superior quality. The incumbent must be able to work effectively with colleagues both internally (i.e., cross-functional teams or within PQ department) and externally to ensure that GMP data is available in a timely manner. The ability to handle multiple priorities (and respect timelines) is required in order to surpass milestones. The ability to negotiate, work with and influence a variety of people in a positive manner while identifying and working to solve problems is a requirement of the position. This position requires the incumbent to make sound and timely decisions. The incumbent must be able to use leadership skills and act as a delegate to the PQ Deputy Director. Safety/ HSE Responsibilities: Each employee is responsible for their personal safety and the achievement of their department and company HSE objectives. Each individual is required to: Understand the compliance requirements (Legal and Sanofi Pasteur) and the hazards/ environmental impacts associated with their duties. Support safety procedures and requirements established in SPAs and Departmental PASS objectives.  Attend required HSE training and apply information learned. Actively participate in accident-prevention and self-inspection programs Identify unsafe conditions/behaviors and take prompt action to correct these by reporting compliance concerns, hazards and unsafe conditions to management and site HSE.  Immediately report accidents/incidents to their supervisor and report any injury or illness to the Health Center. Basic Qualifications: Education/Experience Specific degree, duration of experience (Required to hold the job): Minimum Bachelor Degree preferably in Life Sciences. Required 5 - 7yrs experience in a cGMP controlled/ pharmaceutical industry, preferably in a regulated Quality environment. Key technical competencies and soft skills: Excellent analytical, communication, interpersonal skills, as well as strong organizational and teamwork abilities. Knowledge of the cGMPs (US, Canada, Japan, Europe). Preferred Qualifications: Additional experiencesupporting regulatory agency inspections is desired. Experience in SAP, EDMS, LIMS, TrackWise, and project/process team membership is highly preferred. Certifications - N/A Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Pasteur Glassdoor: #GD-SP     job id R2474526
Salary Range: NA
Minimum Qualification
5 - 7 years

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